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Anatomic fitting of total artificial hearts for in vivo evaluation.
Artif Organs. 2013 Aug; 37(8):735-41.AO

Abstract

Successful anatomic fitting of a total artificial heart (TAH) is vital to achieve optimal pump hemodynamics after device implantation. Although many anatomic fitting studies have been completed in humans prior to clinical trials, few reports exist that detail the experience in animals for in vivo device evaluation. Optimal hemodynamics are crucial throughout the in vivo phase to direct design iterations and ultimately validate device performance prior to pivotal human trials. In vivo evaluation in a sheep model allows a realistically sized representation of a smaller patient, for which smaller third-generation TAHs have the potential to treat. Our study aimed to assess the anatomic fit of a single device rotary TAH in sheep prior to animal trials and to use the data to develop a three-dimensional, computer-aided design (CAD)-operated anatomic fitting tool for future TAH development. Following excision of the native ventricles above the atrio-ventricular groove, a prototype TAH was inserted within the chest cavity of six sheep (28-40 kg). Adjustable rods representing inlet and outlet conduits were oriented toward the center of each atrial chamber and the great vessels, with conduit lengths and angles recorded for future analysis. A three-dimensional, CAD-operated anatomic fitting tool was then developed, based on the results of this study, and used to determine the inflow and outflow conduit orientation of the TAH. The mean diameters of the sheep left atrium, right atrium, aorta, and pulmonary artery were 39, 33, 12, and 11 mm, respectively. The center-to-center distance and outer-edge-to-outer-edge distance between the atria, found to be 39 ± 9 mm and 72 ± 17 mm in this study, were identified as the most critical geometries for successful TAH connection. This geometric constraint restricts the maximum separation allowable between left and right inlet ports of a TAH to ensure successful alignment within the available atrial circumference.

Authors+Show Affiliations

Medical Device Domain, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia. shaun.gregory1@gmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23461712

Citation

Gregory, Shaun D., et al. "Anatomic Fitting of Total Artificial Hearts for in Vivo Evaluation." Artificial Organs, vol. 37, no. 8, 2013, pp. 735-41.
Gregory SD, Loechel N, Pearcy MJ, et al. Anatomic fitting of total artificial hearts for in vivo evaluation. Artif Organs. 2013;37(8):735-41.
Gregory, S. D., Loechel, N., Pearcy, M. J., Fraser, J., Parnis, S., Cohn, W. E., & Timms, D. (2013). Anatomic fitting of total artificial hearts for in vivo evaluation. Artificial Organs, 37(8), 735-41. https://doi.org/10.1111/aor.12060
Gregory SD, et al. Anatomic Fitting of Total Artificial Hearts for in Vivo Evaluation. Artif Organs. 2013;37(8):735-41. PubMed PMID: 23461712.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Anatomic fitting of total artificial hearts for in vivo evaluation. AU - Gregory,Shaun D, AU - Loechel,Nicole, AU - Pearcy,Mark J, AU - Fraser,John, AU - Parnis,Steven, AU - Cohn,William E, AU - Timms,Daniel, Y1 - 2013/03/05/ PY - 2013/3/7/entrez PY - 2013/3/7/pubmed PY - 2014/4/8/medline KW - Anatomic fit KW - Cardiac surgery KW - Heart failure KW - Total artificial heart SP - 735 EP - 41 JF - Artificial organs JO - Artif Organs VL - 37 IS - 8 N2 - Successful anatomic fitting of a total artificial heart (TAH) is vital to achieve optimal pump hemodynamics after device implantation. Although many anatomic fitting studies have been completed in humans prior to clinical trials, few reports exist that detail the experience in animals for in vivo device evaluation. Optimal hemodynamics are crucial throughout the in vivo phase to direct design iterations and ultimately validate device performance prior to pivotal human trials. In vivo evaluation in a sheep model allows a realistically sized representation of a smaller patient, for which smaller third-generation TAHs have the potential to treat. Our study aimed to assess the anatomic fit of a single device rotary TAH in sheep prior to animal trials and to use the data to develop a three-dimensional, computer-aided design (CAD)-operated anatomic fitting tool for future TAH development. Following excision of the native ventricles above the atrio-ventricular groove, a prototype TAH was inserted within the chest cavity of six sheep (28-40 kg). Adjustable rods representing inlet and outlet conduits were oriented toward the center of each atrial chamber and the great vessels, with conduit lengths and angles recorded for future analysis. A three-dimensional, CAD-operated anatomic fitting tool was then developed, based on the results of this study, and used to determine the inflow and outflow conduit orientation of the TAH. The mean diameters of the sheep left atrium, right atrium, aorta, and pulmonary artery were 39, 33, 12, and 11 mm, respectively. The center-to-center distance and outer-edge-to-outer-edge distance between the atria, found to be 39 ± 9 mm and 72 ± 17 mm in this study, were identified as the most critical geometries for successful TAH connection. This geometric constraint restricts the maximum separation allowable between left and right inlet ports of a TAH to ensure successful alignment within the available atrial circumference. SN - 1525-1594 UR - https://www.unboundmedicine.com/medline/citation/23461712/Anatomic_fitting_of_total_artificial_hearts_for_in_vivo_evaluation_ L2 - https://doi.org/10.1111/aor.12060 DB - PRIME DP - Unbound Medicine ER -